Coupling syringe system and methods for obtaining a mixed composition

Abstract

The present invention relates generally to medical devices for mixing, preparing and administering therapeutic compositions, and more particularly to a system comprising two syringes and a locking ring wherein two compositions are mixed between the two syringes immediately prior to administration.

1. A coupling syringe system comprising:
 a first syringe including a first syringe barrel having a first syringe distal end, the first syringe further including a first syringe tip with an integral male end portion, an inner surface of the male end portion forming a single fluid passage, and a locking ring at the first syringe distal end, wherein the locking ring is spaced from an outer surface of the male portion; 
 a first syringe plunger slidably disposed within the first syringe barrel and configured to move to a position at the first syringe distal end, a first volume of a first composition is retained within the first syringe barrel including the first syringe tip; 
 a second syringe including a second syringe barrel having a second syringe distal end, the second syringe further including at the second syringe distal end a second syringe tip with an integral female end portion coupled with the second syringe barrel and one or more exteriorly protruding members adapted to detachably fit the locking ring, wherein the female end portion has an opening defined by an opening wall, which supports the one or more exteriorly protruding members; 
 a second syringe plunger slidably disposed within the second syringe barrel and configured to move to a position at the second syringe distal end, a second volume of a second composition is retained within the second syringe barrel; 
 wherein the first syringe and the second syringe are each sized to contain a single dose; and 
 wherein, when the first and second syringes are coupled, the male end portion is received by the opening of the female end portion at the first and second syringe distal ends, the single fluid passage of the integral male end portion extends into the female end portion between the first and second syringe barrels, and the opening wall and the one or more exteriorly protruding members are received by the spacing between the locking ring and the outer surface of the male end portion, thereby allowing for a single, fluid tight attachment site configured for back and forth transfer and mixing of the first and second volumes of the first and second compositions between the first and second syringes through the single fluid passage, wherein a mixing volume including the first and second volumes is substantially fully transitioned between the first and second syringes in corresponding first and second mixing configurations:
 in the first mixing configuration, the mixing volume is substantially fully retained within the first syringe barrel, and 
 in the second mixing configuration, the mixing volume is substantially fully retained within the second syringe barrel. 
 
 
     
     
       2. The coupling syringe system of  claim 1 , wherein the locking ring is configured to detachably connect to a discharge assembly. 
     
     
       3. The coupling syringe system of  claim 2 , wherein the discharge assembly comprises a needle cannula and a hub joined to a proximal end of the cannula, and wherein the male end portion at least partially fits into, and frictionally engages, the hub when the discharge assembly and the locking ring are detachably connected. 
     
     
       4. The coupling syringe system of  claim 1 , wherein the integral female end portion of the second syringe is detachably connected to the integral male end portion of the first syringe via engagement of the one or more exteriorly protruding members and one or more threads on an inward-oriented surface of the locking ring, which extend toward a syringe axis. 
     
     
       5. The coupling syringe system of  claim 1 , wherein the integral female end portion of the second syringe is detached from the integral male end portion of the first syringe. 
     
     
       6. The coupling syringe system as recited in  claim 1 , further comprising an outwardly projecting flange near the first syringe proximal end. 
     
     
       7. The coupling syringe system as recited in  claim 1 , further comprising an outwardly projecting flange near the second syringe proximal end. 
     
     
       8. The coupling syringe system as recited in  claim 1 , wherein the locking ring is rotatably coupled relative to the integral male end portion of the first syringe. 
     
     
       9. The coupling syringe system as recited in  claim 1 , wherein the locking ring surrounds the male end portion and is threadingly coupled with the one or more exteriorly protruding members, and wherein the one or more exteriorly protruding members are disposed on an outward-oriented surface of the opening wall, extending away from a syringe axis, of the female end portion. 
     
     
       10. The coupling syringe system as recited in  claim 1 , wherein the integral male end portion of the first syringe is disposed within the integral female end portion of the second syringe. 
     
     
       11. The coupling syringe system as recited in  claim 1 , wherein the locking ring is rotatably coupled with the integral male end portion of the first syringe and the locking ring is threadingly coupled with the one or more exteriorly protruding members of the second syringe. 
     
     
       12. The coupling syringe system as recited in  claim 1 , wherein the the first composition includes a drug delivery system. 
     
     
       13. The coupling syringe system as recited in  claim 12 , wherein the second composition includes a drug. 
     
     
       14. The coupling syringe system as recited in  claim 13 , wherein the drug includes lyophilized leuprolide acetate. 
     
     
       15. The coupling syringe system as recited in  claim 12 , wherein the drug delivery system includes Poly (D,L-lactide-co-glycolide) dissolved in a biocompatible solvent N-methyl 2-pyrrolidone. 
     
     
       16. The coupling syringe system as recited in  claim 1 , wherein the first syringe is directly coupled to the second syringe such that no independent coupling means is present therebetween. 
     
     
       17. The coupling syringe system as recited in  claim 1 , wherein the first syringe is configured for administration to a patient and wherein the first syringe is approximately the same size as the second syringe. 
     
     
       18. The coupling syringe system as recited in  claim 1 , wherein the first syringe including the first syringe tip with the integral male end portion is defined by a unitary body; and
 wherein the second syringe including the second syringe tip with the integral female end portion is defined by a unitary body. 
 
     
     
       19. A coupling syringe system for forming a mixed medical composition, the system comprising:
 a first single dose syringe including a first syringe barrel having a first syringe distal end, the first syringe barrel further including a first syringe tip with an integral male end portion having a single two-way fluid passage formed with an inner surface of the male end portion and a locking ring at the first syringe distal end, wherein the locking ring is spaced from an outer surface of the male end portion; 
 a first syringe plunger slidably disposed within the first syringe barrel and configured to move to a position at the first syringe distal end, a first volume of a first composition is retained within the first syringe barrel including the first syringe tip; 
 a second single dose syringe including a second syringe barrel having a second syringe distal end, the second syringe further including at the second syringe distal end a second syringe tip with an integral female end portion coupled with the second syringe barrel, wherein the female end portion comprises one or more exteriorly protruding members adapted to detachably fit the locking ring and an opening defined by an opening wall; 
 a second syringe plunger slidably disposed within the second syringe barrel and configured to move to a position at the second syringe distal end, a second volume of a second composition is retained within the second syringe barrel; and 
 wherein, when the first and second syringes are coupled, the male end portion is received by the opening of the female end portion at the first and second syringe distal ends, the single two-way fluid passage of the integral male end portion extends into the female end portion between the first and second syringe barrels, and the opening wall and the one or more exteriorly protruding members are received by the spacing between the locking ring and the outer surface of the male end portion, thereby allowing for a single, fluid tight attachment site configured for back and forth transfer and mixing of the first and second volumes through the single two-way fluid passage between the first syringe and the second syringe, wherein a mixing volume including the first and second volumes of the is substantially fully transitioned between the first and second syringes in corresponding first and second mixing configurations:
 in the first mixing configuration, the mixing volume is substantially fully retained within the first syringe barrel, and 
 in the second mixing configuration, the mixing volume is substantially fully retained within the second syringe barrel. 
 
 
     
     
       20. The coupling syringe system as recited in  claim 19 , wherein the locking ring couples the first syringe to the second syringe and forms a fluid tight engagement configured for back and forth transfer of the drug delivery system and the drug between the syringes. 
     
     
       21. The coupling syringe system as recited in  claim 19 , wherein the drug includes lyophilized leuprolide acetate. 
     
     
       22. The coupling syringe system as recited in  claim 19 , wherein the drug delivery system includes Poly (D,L-lactide-co-glycolide) dissolved in a biocompatible solvent N-methyl 2-pyrrolidone. 
     
     
       23. The coupling syringe system as recited in  claim 19 , wherein, when the first and second syringes are coupled, movement of the first syringe plunger toward the second syringe effectuates delivery of one or both of the drug delivery system or the drug through the male end portion and directly into the second syringe barrel.